- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927316
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
November 9, 2009 updated by: Region Skane
Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes?
The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1).
After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2).
During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, SE-221 85
- Department of Urology, Lund University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recurrent UTI
- Bladder emptying dysfunction
- Optimal conservative treatment incl. clean intermittent catheterization
- Capable of "self reporting of UTI episodes"
Exclusion Criteria:
- Malignant disease
- Immunosuppression
- Recurrent pyelonephritis
- Abnormalities within upper urinary tract, including renal stones and poor kidney function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active arm
E. coli 83972 bacteriuria
|
Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml. |
Placebo Comparator: Placebo arm
Monitoring
|
Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to UTI
Time Frame: 12 months
|
12 months
|
Number of UTI
Time Frame: During 12 months placebo or active treatment
|
During 12 months placebo or active treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Fredrik Sundén, MD, Dept. of Urology, University Hospital, 221 85 Lund
- Study Chair: Björn Wullt, MD, PhD, Dept. of Urology, Lund University Hospital, 221 85 Lund
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
June 22, 2009
First Submitted That Met QC Criteria
June 23, 2009
First Posted (Estimate)
June 24, 2009
Study Record Updates
Last Update Posted (Estimate)
November 10, 2009
Last Update Submitted That Met QC Criteria
November 9, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTP-A2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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